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United States · US · US:51407-982_50013854-7707-b34d-e063-6294a90abc37

Phenytoin Sodium

Orange BookUNIISPLATC N03AB02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGolden State Medical Supply, Inc.
CountryUS (United States)
ATC codeN03AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5140798201
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-982-01)
  • ndc11
    5140798210
    1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-982-10)

Annotations

UNII (FDA Substance ID)
4182431BJH
PHENYTOIN SODIUM
RxCUI 71227
Orange Book
A040684
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4182431BJH",
    "rxcui": "71227",
    "inchikey": "FJPYVLNWWICYDW-UHFFFAOYSA-M",
    "display_name": "PHENYTOIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3580e6a8-f7c3-44a0-a1eb-2a84ae589d21": {
      "match": "brand_token",
      "title": "PHENYTOIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PRASCO LABORATORIES]",
      "spl_version": "7",
      "published_date": "2026-06-01"
    }
  },
  "productid": "51407-982_50013854-7707-b34d-e063-6294a90abc37",
  "productndc": "51407-982",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "040684",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG EXTENDED",
        "product_no": "001",
        "approval_date": "Sep 5, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHENYTOIN SODIUM",
  "proprietary_name": "Phenytoin Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040684",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phenytoin Sodium",
  "start_marketing_date": "20060905",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N03AB02.

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